Clinical Trial Operations

  • Carl L. Roland
  • Paul Litka

This chapter focuses on the activities and operations related to the conduct of clinical trials for new product development, applicable to both U.S. and non-U.S. trials as well. Although the focus of this chapter is on the development of new drugs (including biologics), many of the principles are also applicable to medical device development. Note, however, that while similarities in principle exist, device development is governed by separate U.S. federal regulations. Clinical trial operations are based on good clinical practices, best possible science, use of technology, best business practices, optimal management principles, people with expertise and interpersonal skills, the regulations and laws from governing agencies, and some good common sense. These eight areas, that is, skills and attributes, will be brought into the discussions in this chapter to best elaborate upon operations for clinical trials.


Development Plan Package Insert Clinical Operation Investigator Initiate Clinical Data Management 


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Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Carl L. Roland
    • 1
  • Paul Litka
    • 2
  1. 1.Clinical ResearchKing PharmaceuticalsNC
  2. 2.Pharmaceutical industry and clinical research organizationsUT

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